Medication dose preparation and transfer system

ABSTRACT

Apparatus, systems, methods and articles are described to prepare and track medications and medication containers as they are prepared, administered to patients and, in some cases, disposed of. Information such as medication type, concentration, and volume are associated with medication containers during preparation and this information can later be consumed/utilized when administering the medication from a container to a patient. Disposing of any remaining medication can also be tracked.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S.application Ser. No. 13/524,736, entitled “Medication Dose Preparationand Transfer System” filed Jun. 15, 2012, which claims priority to U.S.Provisional Application Ser. No. 61/497,855, filed Jun. 16, 2011, theentire contents of each of which are hereby fully incorporated byreference.

FIELD OF THE INVENTION

The subject matter described herein relates to a medication dosepreparation and transfer apparatus used for identifying medicationwithin a medication container, measuring an amount of medicationwithdrawn from the medication container and transferred to a secondarycontainer (e.g. syringe), tracking the amount of medication actuallyadministered to a patient and tracking the amount of any residualmedication disposed of as waste.

BACKGROUND OF THE INVENTION

There are a number of patient clinical settings including in-hospital,outpatient and emergency medical services (EMS) that require transfer ofmedications from original pharmaceutical manufacturer's primarycontainers to secondary containers to facilitate caregiveradministration to patients. When medications are transferred tosecondary containers it is standard clinical best practice to label themto reduce the potential for medication errors. However, due to dosemeasurement mistakes, incorrect transfer of labeling information andother factors, errors continue to occur when caregivers transfermedications from primary containers (vials to syringes) or preparepartial doses (empty syringe withdraws of a partial amount from aprimary vial).

SUMMARY OF THE INVENTION

In one aspect, an apparatus for transferring medication from a primarymedication container to a manually injectable secondary medicationcontainer is provided. The apparatus includes a fluid channel, a primarymedication container coupling, a secondary medication coupling, at leastone identification sensor and a communications module. The fluid channelterminates at a primary medication container port on a first end and asecondary medication container port on a second end. The primarymedication container coupling is configured to fluidically couple theprimary medication container to the primary medication container port.The secondary medication container coupling is configured to fluidicallycouple the secondary medication container to the secondary medicationcontainer port. The at least one identification sensor senses (i) aninformation transfer element on the primary medication container and(ii) an information transfer element on the secondary medicationcontainer with the information transfer element on the primary containerbeing used to characterize the medication. The communications moduletransmits data obtained by and/or derived from the at least oneidentification sensor to a remote computing system to associate themedication in the primary medication container as having beentransferred to the secondary medication container.

The primary medication container coupling can include a spike topenetrate a barrier of the primary medication container. The secondarymedication container coupling can include a femaleluer fitting to matewith a male luer fitting of the secondary medication container. Theprimary medication container can be vial with a vial adapter having theinformation transfer element disposed thereon.

The secondary medication container can be a syringe with the informationtransfer element disposed upon an encoded hub attached to a fluid outletof the syringe (which in turn is configured to fluidically couple withthe secondary medication container port). The communications module canwirelessly transmit data to and/or receive data from the remotecomputing system.

A first identification sensor can sense the information transfer elementof a primary medication container and a second identification sensor cansense the information transfer element of the secondary medicationcontainer. The information transfer element on at least one of theprimary medication container and the secondary medication container caninclude or be a unique identifier such as a serial number.

The at least one flow sensor can characterize an amount of medicationpassing through the fluid channel such that the communications moduletransmits data indicating same. In some implementations, the at leastone flow sensor can be a bi-directional flow sensor measuring fluid flowin two opposing directions and the data transmitted can separatelycharacterize fluid flow in both opposing directions.

Memory can be included that stores data such as data obtained from theat least one identification sensor and/or the at least one flow sensor.At least one data processor (e.g., a CPU/microprocessor, etc.) canprocess data stored in the memory.

A user indicator (e.g., an interface, display, etc.) can be providedthat provides visual and/or audio feedback to a user. The indicator canbe interactive allowing the user to change one or more operatingparameters (e.g., alarm override, enter patient information and thelike). The user indicator can display a wide range of information,including but not limited to: medication name, medication category,recommended dosage, secondary medication container fill volume,medication waste volume, secondary medication container identifier, andpartial dosage volume.

In some implementations, the entire apparatus can be disposable. Inother implementations, only a portion of the apparatus is disposable(with the remaining portion being reusable). With this latterarrangement, the fluid channel can be selectively removable to avoidmedication cross-contamination and/or sterility issues. With a removablefluid channel, there can be memory within or otherwise coupled to theremovable fluid channel. Such memory can have and/or store a uniqueidentifier (e.g., serial number, etc.).

The remote computing system can be, for example, one or more ofmedication management devices and systems, electronic medical recordssystems, pharmacy management and fulfillment systems, medication storagesystems, medication dispensing stations, and medication waste disposalsystems.

The fluid channel can undertake a variety of geometries. It can belinear, at least partially curved, and angled. With the latter, thefluid channel can have at least one 90 degree angle, and in oneimplementation, it can have at least two 90 degree angles.

The fluid channel can terminate at a patient outlet which can, forexample, lead to an IV line for a patient. The fluid channel can includea first sub-channel connecting the primary medication container portwith the patient outlet and a second sub-channel extending at an anglefrom the first sub-channel terminating on one end at the firstsub-channel and on a second end at the secondary medication containerport. A bi-directional flow sensor can measure the flow of medication inboth directions within the second sub-channel as it is transferred tothe secondary medication container and as it is expelled from thesecondary medication container. With such an arrangement, thecommunications module can transmit data characterizing the medicationflow detected by the bi-direction sensor.

At least one check valve can be incorporated to prevent the medicationexpelled from the secondary medication container from flowing towardsthe primary medication container port and/or to prevent medicationextracted from the primary medication container from flowing backtowards the primary medication container port. Removable channel capscan be employed that are secured to the primary medication containerport and the secondary medication container port.

A housing can be provided through which the fluid channel traverses.Such housing can have a size and shape to allow a user to hold thehousing and a primary medication container in a first hand and tooperate the manually injectable secondary medication container using asecond hand.

The fluid channel can include a primary fluid channel terminating at twosub-channels. The two sub-channels can be at an angle in relation to theprimary fluid channel and being parallel in relation to each other, thesub-channels respectively terminating in the primary medicationcontainer port and the secondary medication container port.

A display can be displayed on a housing (i.e., an outer surface of ahousing) that envelopes the fluid channel. The communications module canreceive data from at least one computing system characterizing themedication, at least a portion of the received data being displayed onthe display. It will be appreciated that the communications module cantransmit data to a first computing system while receiving data from asecond computing system. At least a portion of the information beingdisplayed can include one or more of: information about the fluidtransfer process, user guidance, information about the dose to beadministered, information about the dose administered to a patient, andpatient specific medication administration guidelines or restrictions.The received data can include one or more of: medication delivery orderdata, patient-specific identifiers, general or medication-specificdosing limits, data for contraindication checking, Broselowcolor/classification, patient drug allergies, patient weight, medicationdata, patient specific data, procedural cautionary data, errorprevention data, dose time data, physician instructions, drugmanufacturer instructions, precautions associated with the medication,and contraindications associated with the medication.

The at least one identification sensor can detect the informationtransfer element using one or more technologies such as optical,magnetic, mechanical, conductive, capacitive, inductive, proximitysensors, infrared, and switchable RFID.

In an interrelated aspect, an apparatus for transferring medication froma primary medication container to a manually injectable secondarymedication container includes a fluid channel, a primary medicationcontainer, a secondary medication container, at least one fluid flowsensor, and a communications module. The fluid channel terminates at aprimary medication container port on a first end and a secondarymedication container port on a second end. The primary medicationcontainer coupling is configured to fluidically couple the primarymedication container to the primary medication container port. Thesecondary medication container coupling is configured to fluidicallycouple the secondary medication container to the secondary medicationcontainer port. The at least one flow sensor to sense medicationsflowing through the fluid channel. The communications module transmitsdata obtained by and/or derived from the at least one flow sensor to aremote computing system and, in some implementations, receives data fromone or more remote computing systems associated with the medicationand/or the patient.

Systems can be provided that additionally include a dose preparation andtransfer apparatus and one or more of a primary medication container andmanually injectable secondary medication container. Kits can be providedthat include dose preparation and transfer apparatus as well as one ormore of a primary medication container and a manually injectablecontainer.

In a further interrelated aspect, a dose preparation and transferapparatus detects a medication identification code (information transferelement) on a primary medication container, detects an identifier(information transfer element) of a secondary medication container, andtransmits data to a remote computing system that characterizes thedetected medication identification code and the detected identifier. Insome implementations, the dose preparation and transfer apparatusfurther detects an amount of medication transferred from the primarycontainer to the secondary container and data characterizing same istransmitted to the remote computing system.

Apparatus, systems, methods and articles are described to prepare andtrack medication containers as they are prepared, administered topatients and, in some cases, disposed of. Information such as medicationtype, concentration, and volume are associated with medicationcontainers during preparation and this information can later beconsumed/utilized when administering the medication from a container toa patient. Disposing of any remaining medication can also be tracked(which can be advantageous in connection with controlled substances). Insome examples, medication is transferred from a container such as a vialinto a syringe and data characterizing the medication is associated withthe syringe (e.g., a bar code, a record in a look-up table, etc.). Themedication in this syringe can then be injected into a patient via, forexample, a medication injection site which can automatically identifythe medication container and/or its contents. Any remaining contents ofthis syringe can be injected into a waste disposal system which can alsoautomatically identify the medication container and/or its contents (andlog the container and amount of disposed medication disposed).

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, show certain aspects of the subject matterdisclosed herein and, together with the description, help explain someof the principles associated with the disclosed embodiments. In thedrawings:

FIG. 1 is a diagram illustrating a medication dose preparation andtransfer system;

FIG. 2 is a diagram describing a detailed view of a medication dosepreparation and transfer system as in FIG. 1;

FIG. 3 is a diagram describing a detailed view of a second medicationdose preparation and transfer system as in FIG. 1;

FIG. 4 is a diagram describing a detailed view of a third medicationdose preparation and transfer system as in FIG. 1;

FIG. 5 is a diagram describing a detailed view of a fourth medicationdose preparation and transfer system as in FIG. 1;

FIG. 6 is a diagram describing the assembly of a medication dosepreparation and transfer apparatus with medication containers as in FIG.3;

FIG. 7 is a diagram describing a detailed view of a fifth medicationdose preparation and transfer system as in FIG. 1;

FIG. 8 is a diagram describing the assembly of a medication dosepreparation and transfer apparatus with medication containers as in FIG.7;

FIG. 9 depicts the basic steps taken in the use of a medication dosepreparation and transfer system as in FIG. 3;

FIG. 10 is a diagram illustrating a medication dose preparation andtransfer apparatus as in FIG. 3 with a display;

FIG. 11 is a diagram illustrating a second medication dose preparationand transfer apparatus as in FIG. 3 with a display;

FIG. 12 is a diagram showing the sequence of operation for the device inFIG. 11;

FIG. 13 is a diagram describing a detailed view of a sixth medicationdose preparation and transfer system as in FIG. 1;

FIG. 14 is a diagram describing a detailed view of a seventh medicationdose preparation and transfer system as in FIG. 1;

Like reference symbols in the various drawings indicate like or similarelements.

DETAILED DESCRIPTION

FIG. 1 is a diagram illustrating a medication dose preparation andtransfer system 2. System 2 comprises primary medication container 4,secondary medication container 6, dose preparation and transferapparatus 8 and interconnecting dose transfer fluid channel 10. Fluidchannel 10 can include spike 14 for connection to primary medicationcontainer 4 and female luer fitting 15 for connection to secondarycontainer 6. Following attachment of container 4 and container 6, fluidfrom container 4 can be transferred to container 6 through dose transferchannel 10. Information 18 about containers 4 and 6 and the medicationtransferred through fluid channel 10 can be transmitted (via, forexample, a communications module) to recordkeeping system 30 (which maybe coupled wirelessly, via a hard-wired communications network, or acombination of both). Recordkeeping system 30 (including healthcareinformation computing systems) can include one or more of: medicationmanagement devices and systems, electronic patient medical records,medication administration records, pharmacy records, medication storagestation inventory records, records accounting for the disposal ofmedication wastes, and the like.

A healthcare provider can select vial 4 from an array of available vialsand transfer the medication and medication information to a patient'smedication injection site for administration. Examples of medicationinjection sites and related data collection systems are described inU.S. patent application Ser. Nos. 12/614,276, 12/765,707 and 12/938,300all entitled “Medication Injection Site and Data Collection System,” thecontents of which are hereby fully incorporated by reference.

Medication container 4 and secondary container 6 can be joined by a dosepreparation and transfer apparatus 8 to form medication dose preparationand transfer system 2. Housing 12 can contain hardware, software andmechanical elements for characterizing the transferred medication (e.g.,identify and measure amount of transferred medication, determinetransfer time, etc.). A dose transfer fluid channel 10 can connect eachcontainer (4 and 6) forming a transfer pathway. Fluid channel 10 can beintegrated within housing 12 or be separate. When separate, housing 12is reusable and can be used with many fluid channels 10 that can be madesterile and disposable for single patient use. Disposable flow channel10 can be sterilized and be part of a kit including a sterile pouchenveloping the disposable sub-housing. Housing 12 and/or fluid channel10 can be assigned serial numbers for identification which can be readby or received from recordkeeping system 30. One end of fluid channel 10can have spike 14 to puncture medication container 4 to access themedication for transfer to secondary container (e.g. syringe) 6. Theother end of fluid channel 10 can be a female luer type fitting 15 toaccept a male luer fitting on secondary container 6.

The dose preparation and transfer apparatus 8 allows a desired amount ofmedication in vial 4 to be transferred to a syringe 12 through fluidchannel 10. Syringe 6 can initially be provided empty, or in the case ofa medication mixture or dilution, can contain an existing volume offluid. Syringe 6 can be attached to the medication dose preparation andtransfer device to withdraw the medication from vial 4. Primarymedication container 4's contents can be identified using an informationtransfer element ID Code 102 (medication name, manufacturer name, drugconcentration, NDC code, volume contained, serial number, and other drugor patient specific information) on or associated with primarymedication container 4. Secondary medication container 6 can beidentified using an information transfer element (ID Code 106). These IDCodes will be described below.

FIG. 2 is a diagram describing a detailed view of a medication dosepreparation and transfer system 2 as in FIG. 1. At the top of thefigure, primary medication container (vial) 4 contains medication 20. Atthe bottom of vial 4 the open end can be closed by rubber closure andprotected by flip off cap. Vial 4 can carry an information source (e.g.,medication ID code 102) that provides detectable information indicativeof the medication in primary container 4 and/or of the volume of thecontents. Primary medication container (Vial) 4 as used herein refers toboth vials and other medication containers such as pre-filled syringesand/or bags (except when explicitly disclaimed). It can be appreciatedthat many configurations of vial 4 can be manufactured and can functionin system 2.

At the bottom of the figure, secondary container 6 can be a syringe witha syringe body, male luer fitting tip, plunger and plunger rod. It canbe appreciated that many configurations of secondary container 12 can bemanufactured and can function in system 2.

FIG. 2 further illustrates a medication dose preparation and transfersystem 2 that comprises medication container adapter (vial adapter) 16joined with information transfer element (ID Code 102). Vial adapter 16can be a sterilizable plastic material and can comprise vial spike,spike cover, vial clips, a flow channel and a female luer fitting. Itcan be appreciated that many configurations of vial adapter 16 can bemanufactured and can function in system 2 (provided that the vialadapter can create a sterile fluid pathway between the vial contents andthe dose transfer fluid channel 10). Examples of vial adapter devicesare described in U.S. patent application Ser. No. 13/282,255 entitled“Medication and Identification Information Transfer Apparatus”, thecontents of which is hereby fully incorporated by reference.

The vial adapter 16 can be a sterilizable injection molded plasticmaterial consisting of element body, fluid inlet, fluid outlet, flowchannel and ID Code 102.

ID Code 102 can be one or more of an optical source, a magnetic source,a mechanical source, a switchable RFID source, a conductive source,and/or a proximity source. One implementation can provide informationencoded within the information element in the form of an opticallydetectable surface, reflective or absorbing light surface, and can beembedded into or on top of element body.

Alternatively, information provided by ID Code 102 can be a magneticallydetectable strip similar to a credit card magnetic strip, facilitating amagnetic scan similar to credit card swiping, that is embedded into oron top of the information element body.

Further and alternatively, information provided by the informationelement can be a mechanically detectable feature consisting of Braillelike features of bumps or ridges or valleys on the surface of or at theend of element body, facilitating mechanical detection by a micro switchor similar physical detection method.

Further and alternatively, information provided by information elementcan be an RFID tag located on the surface of element body, facilitatingdetection by an RFID reader. The antenna of the RFID tag can beswitchable and can be OPEN prior to connection to the medication dosepreparation and transfer apparatus 8. Upon connection to the dosepreparation and transfer apparatus 8, the antenna can become CLOSED (orconnected) facilitating RFID reader detection. When the container isdisconnected from the dose preparation and transfer apparatus, the RFIDtag antenna can again become OPEN.

Further and alternatively, information provided by information transferelement ID Code 102 can be in the form of a capacitive or inductiveproximity feature on the surface of or embedded into element body,facilitating capacitive or inductive proximity detection.

The information element can be an integrated feature of the informationtransfer element such as etched or molded features. The informationelement can alternatively be adhered or deposited to the element body(i.e., information element can be a label, etc.) or embedded therein. Inaddition, the information element can be a separate element that extendsaround fluid outlet 54.

The encapsulated data within ID Code 102 can be formatted using anindustry standard representation of the medication being characterizedor a proprietary representation of the medication being characterized.The data can include one or more of: an NDC code (National Drug Code), asegment of the NDC code identifying the drug product, a segment of theNDC code identifying the drug package, a unique identifier code, a humanreadable alphanumeric, a machine readable code, a name of themedication, a manufacturer of the medication, a re-packager of themedication, a distributor of the medication, a strength of themedication, a dosage form of the medication, dose instructions for themedication, administration instructions for a specific patient,medication formulation, medication package form, medication packagesize, medication contained volume, medication package serial number,medication lot number, and medication expiration date. The encapsulateddata can additionally or alternatively also include such information.

The ID Code 102 can be applied by any number of operations or steps inthe medication supply chain prior to medication administration to apatient including, but not limited to: the original medicationmanufacturer, a pharmaceutical re-packager, a hospital pharmacy, acompounding pharmacy service, a healthcare professional or caregiver, apatient.

Secondary container 6 can be encoded with ID Code 106 to identify thecontainer. ID Code 106 can be a unique number, code, symbol, serialnumber, random number, or other information describing a specific uniquesecondary container 6. A medication dose can be transferred from primarycontainer 4 through fluid channel 10 into secondary container 6 bypulling on the plunger rod of syringe 6 and drawing medication dose 22into it.

The ID Code 106 can be applied by any number of operations or steps inthe supply chain of secondary container 6 prior to medication transferincluding, but not limited to: the original secondary containermanufacturer, a pharmaceutical re-packager, a compounding pharmacyservice, a hospital pharmacy, a healthcare professional or caregiver, apatient. ID Code 106 can be one or more of an optical source, a magneticsource, a mechanical source, a switchable RFID source, a conductivesource, and/or a proximity source. One implementation can provideinformation encoded within the information element in the form of anoptically detectable surface, reflective or absorbing light surface, andcan be embedded into or on top of the element body.

Alternatively, information provided by ID Code 106 can be a magneticallydetectable strip similar to a credit card magnetic strip, facilitating amagnetic scan similar to credit card swiping, that is embedded into oron top of the information element body.

Further and alternatively, information provided by the informationelement can be a mechanically detectable feature consisting of Braillelike features of bumps or ridges or valleys on the surface of or at theend of element body, facilitating mechanical detection by a micro switchor similar physical detection method.

Further and alternatively, information provided by ID Code 106'sinformation element can be an RFID tag located on the surface of elementbody, facilitating detection by an RFID reader. The antenna of the RFIDtag can be switchable and would be OPEN prior to connection to themedication dose preparation and transfer apparatus 8. Upon connection tothe medication dose preparation and transfer apparatus 8, the antennacan become CLOSED (or connected) facilitating RFID reader detection.When the container is disconnected from the dose preparation andtransfer apparatus, the RFID tag antenna can again become OPEN.

Further and alternatively, information provided by ID Code 106'sinformation element can be in the form of a capacitive or inductiveproximity feature on the surface of or embedded into element body,facilitating capacitive or inductive proximity detection.

ID Code 106's information element can be an integrated feature of theinformation transfer element such as etched or molded features. Theinformation element can alternatively be adhered or deposited to theelement body (i.e., information element can be a label, etc.) orembedded therein. In addition, the information element can be a separateelement that extends around fluid outlet. Further, ID Code 106 can bepart of an extension or a similar vial adapter adapter 16 that canattach to the fluid outlet of secondary container 6 in a way that onceconnected becomes permanently or semi-permanently affixed.

Dose preparation and transfer apparatus 8 can have housing 12 thatencloses a power source 115, hardware and software elements 110 and 114.Within apparatus 8 are dose transfer fluid channel 10 (either built-inor separately clipped-in), medication container emitter/detector 104 todetect and transfer ID Code 102 to microprocessor/memory 114, secondarycontainer emitter/detector 108 to detect and transfer ID Code 106 tomicroprocessor/memory 114 (e.g., a data processor, etc.), volume/flowtransducer 118 to monitor and measure fluid transfer, a user indicator116 can be provided to indicate various steps in the process and providefeedback to the user. Other user indicators can include a display whichwill be discussed later.

When dose transfer fluid channel 10 is separate from dose preparationtransfer apparatus 8, fluid channel 10 can be clipped-in in any numberof ways to facilitate mating with apparatus 8 for the connection ofvolume/flow transducer 118 to monitor and measure fluid transferincluding, but not limited to: snap fit of fluid channel 10 into acavity within housing 12, snap fit of fluid channel 10 onto the outsideof housing 12, an electrical connector, an inductive connector, anoptical connection, etc.

Alternately, the separate fluid channel 10 can include volume/flowtransducer 118 and/or a memory element 119. The memory element 119 caninclude any one of calibration data, serial number or other uniqueinformation.

Dose preparation transfer apparatus 8 can also contain a communicationsmodule (sometimes referred to as a wireless radio) 110 for transmissionof information 18 to a remote recordkeeping system 30. Recordkeepingsystem 30 will be discussed later and can be a remote computing system.Information 18 can be bi-directional and can include transfer of datafrom recordkeeping system 30 (including a medication management systemor a healthcare information system) to dose preparation and transferapparatus 8. Information that can be transferred from record keepingsystem 30 to dose transfer apparatus 8 includes but is not limited tomedication delivery order data, patient-specific identifiers, general ormedication-specific dosing limits, data for contraindication checking,Broselow color/classification, patient drug allergies, patient weight,or other information relevant for ensuring the medication beingtransferred is the right medication and that the resultant dosetransferred to secondary container 6 is correct for the intended patientuse.

FIG. 3 is a diagram describing a detailed view of a second medicationdose preparation and transfer system as in FIG. 1. In this variation,medication ID Code 102 can be placed on the closure rim of the primarymedication container 4. No vial adapter 16 is needed. Here, medicationcontainer emitter/detector 104 can directly identify medication ID Code102 from primary medication container (vial) 4. The other features andfunctions of dose preparation and transfer apparatus 8 described in FIG.2 can be the same.

FIG. 4 is a diagram describing a detailed view of a third medicationdose preparation and transfer system as in FIG. 1. In this variation,medication ID Code 102 is placed on the outlet of a prefilled syringe 4.Here, medication container emitter/detector 104 can directly identifymedication ID Code 102 from primary medication container 4 (syringe).The other features and functions of dose preparation and transferapparatus 8 described in FIG. 2 can be the same.

FIG. 5 is a diagram describing a detailed view of a fourth medicationdose preparation and transfer system as in FIG. 1. In thisimplementation, medication ID Code 102 can be placed on the closure rimof primary medication container 4 and secondary container (syringe) 6and located at right angle (or any angle convenient to facilitate use)to the fluid transfer channel 10. Here, medication containeremitter/detector 104 can directly identify medication ID Code 102 fromprimary medication container 4 (vial). Secondary containeremitter/detector 108 can identify ID Code 106. Additionally dosetransfer fluid channel 10 can form a “T” (or other angled junction).

A single direction set of check valves 120 can be located at thejunction to control flow through channel 10. When a plunger rod of thesecondary container (syringe) 6 is pulled (withdrawn), fluid is removedfrom primary medication container 4 and passes into syringe 6. Theupstream check valve allows flow to the secondary container 6 and thedownstream check valve prevents backflow (or air) from the patientoutlet 122. Here, a volume/flow bi-directional sensor 118 can measurefluid transfer into the secondary container 6 from vial 4. The secondarycontainer 6 can be removed for administration to a patient as in FIG. 3.Alternately, the entire dose preparation and transfer apparatus 8 can beattached to a patient's administration injection port (not shown). Inthis variation, fluid outlet 122 is attached to the injection port andmedication dose 22 is injected by pushing on the syringe plunger rod.Check valves 120 direct flow to the patient. The upstream check valveprevents flow back into primary container 4 and the downstream checkvalve allows fluid flow to the patient. The other features and functionsof dose preparation and transfer apparatus 8 described in FIG. 2 are thesame.

FIG. 6 is a diagram describing the assembly of a medication dosepreparation and transfer apparatus with medication containers as inFIG. 1. Primary medication container 4 and secondary medicationcontainer 6 can be prepared for use by removing their respectiveprotective caps 22 and 24. Dose fluid transfer channel 10 can beprepared by removing channel cap 26 and spike cap 28. These caps protectthe containers and fluid transfer channel 10 when they are providedsterile (fluid path is sterile). Dose preparation apparatus 8 may beheld in a first hand and medication container 4 (vial) is held in asecond hand. Fluid channel 10's fluid inlet spike 14 can be insertedthrough a sterile closure stopper in the vial. Secondly, secondarycontainer 6 can be attached to the fluid channel outlet female lurefitting 15 (this can be a slip luer or luer lock type fitting).

FIG. 7 is a diagram describing a detailed view of a fifth medicationdose preparation and transfer system 2 as in FIG. 1. In thisimplementation dose transfer fluid channel 10 can be “U” shaped. Thiscan provide for an alternate user configuration where both primarycontainer 4 and secondary container 6 are on the same side of dosepreparation apparatus 8. Medication ID Code 102 is placed on the closurerim of the primary medication container 4. Medication containeremitter/detector 104 directly identifies medication ID Code 102 fromprimary medication container (vial) 4. Alternately, fluid transferchannel 10 can be “L” shaped, “J” shaped or otherwise shaped tofacilitate use. The other features and functions of dose preparation andtransfer apparatus 8 described in FIG. 2 can be the same.

FIG. 8 is a diagram illustrating the assembly of a medication dosepreparation and transfer apparatus with medication containers as in FIG.7. Primary medication container 4 and secondary medication container 6can be prepared for use by removing their respective protective caps 22and 24. Dose fluid transfer channel 10 can be prepared by removingchannel cap 26 and spike cap 28. These caps protect the containers andfluid transfer channel 10 when they are provided sterile (fluid path issterile). Dose preparation apparatus 8 may be held in a first hand andmedication container 4 (vial) is held in a second hand. Fluid channel10's fluid inlet spike 14 can be inserted through a sterile closurestopper in the vial. Secondly, secondary container 6 can be attached tothe fluid channel outlet female lure fitting 15. The other steps of dosepreparation and transfer apparatus 8 described in FIG. 6 can be thesame.

FIG. 9 depicts steps that can be taken in the use of a medication dosepreparation and transfer system as in FIG. 3.

Step 1: Containers 4 and 6 are prepared for use by removing theirprotective caps 22 and 24. The dose fluid transfer channel is preparedby removing its caps 26 and 28. Primary container 4 is spiked with theinlet of fluid channel 10 and secondary container 6 is attached to theoutlet of fluid channel 10.

Step 2: Connection of containers 4 and 6 allow emitter/detectors 104 and108 to identify and decode ID Codes 102 and 106 respectively.Information 18 is transmitted to recordkeeping system 30. The two IDCodes can be associated with one another in the recordkeeping system 30,along with an amount of medication transferred between the containersand the volume in each medication container following the transfer.Alternatively, ID Codes 102 and 106 can be associated with one anotherin dose preparation apparatus 8. The assembled dose preparation andtransfer apparatus is inverted allowing withdrawal of medication fromvial 4.

Step 3: Medication is withdrawn from container 4 into container 6 bypulling on the plunger rod of the syringe container (6). Volume/flowsensor 118 measures the transferred medication and the dose preparationand transfer apparatus 8 transmits information 19 (volume/flowinformation) to recordkeeping system 30. The transferred medication dosevolume information 19 is associated with ID Code 106 on secondarycontainer 6. The remaining medication in primary container 4 isassociated with ID Code 102.

Step 4: Secondary container 6 is detached from fluid channel 10 andprotective caps 24 and 26 can be replaced to maintain sterilityprotection. Syringe 6 is then taken to a patient for doseadministration. Alternately, vial 4 and vial spike 14 can be detachedfrom fluid channel 10 and syringe 6 with fluid channel 10 still attachedcan be used to administer medication to a patient (not shown).

Step 5: A caregiver can then administer the dose from syringe 6 to apatient by attaching it to medication injection port 200 on a fluidadministration tubing set. When attached, ID Code 106 is identified byinjection port 200 and that information 21 transmitted to recordkeepingsystem 30. Recordkeeping system 30 associates the injection with themedication withdrawn in Step 3 and medication type and concentrationinformation (ID Code 102) identified in Step 2. The volume of the dosecan be measured by injection port 200 and that information 21 can alsobe transmitted to recordkeeping system 30 for recording in a patient'smedication administration record. Information 21 transmitted torecordkeeping system 30 can be integrated or associated with additionalinformation stored within or accessible by recordkeeping systems 30 andutilized to create paper reports and/or electronic records associatedwith the medication delivery.

The features and functions of medication injection port 200 aredescribed in a medication injection site/medication administrationdevice detailed in the U.S. patent application Ser. Nos. 12/614,276,12/765,707, and 12/938,300 all entitled “MEDICATION INJECTION SITE ANDDATA COLLECTION SYSTEM”. Features and functions of a sample vial adapterand encoded fluid transfer element are detailed in U.S. patentapplication Ser. No. 12/768,509 entitled “MEDICATION AND IDENTIFICATIONINFORMATION TRANSFER APPARATUS”. The contents of each of theaforementioned applications are hereby fully incorporated by reference.Other medication containers and/or vial adapters and fluid transferelements may be implemented with this medication dose preparation andtransfer system 2. Record keeping system 30 can account for and trackmedication transfers and administrations to patients in a medicationdose history for each patient. Additionally, remaining medication invial 4 or syringe 6 can be tracked, accounted for and associated withwaste disposal. The withdrawn transfer medication volume can besubtracted from the original medication volume in syringe 6 to determinethe remaining medication volume. Similarly, the residual medicationvolume in syringe 6 after dosing and be determined by subtracting thevolume of medication delivered to the patient from the total volume ofmedication that was transferred from vial 4 to syringe 6. The disposedof medication can be tracked by a waste disposal system. For example, amedication wasting device can be configured to receive a syringe 6containing a controlled substance and bearing an information transferelement ID Code 106 such that the information transfer element isautomatically read by the medication wasting device when the syringe iscoupled thereto. One example of a medication wasting device is describedin U.S. patent application Ser. No. 13/170,073 entitled: “MedicationWaste Collection Apparatus”, the contents of which are hereby fullyincorporated by reference.

FIG. 10 is a diagram illustrating a medication dose preparation andtransfer apparatus as in FIG. 3 with a display. A display 120 can beincluded on housing 12 of medication dose preparation and transferapparatus 8. Display 120 can include a user interface 130 providinginformation about the fluid transfer process or user guidance to ensurethe medication and volume transferred is correct and appropriate for itsintended use. For example a pediatric dose preparation system caninclude the selection of a pediatric color (Broselow color) or patientweight (kilograms or pounds), an indication of the medication typeand/or concentration connected identified by ID Code 102 andsubsequently recommend a dose or volume for withdrawal from the primarycontainer 4. Pediatric color, patient weight, recommended dose, andother relevant dose preparation parameters can also be downloaded to themedication dose preparation and transfer apparatus 8 from recordkeepingsystem 30 via information transmission 18. When the secondary container6 is attached and the syringe plunger rod is pulled a medication dosecan be removed from the primary container 4 into secondary container 6.That dose transfer is measured by volume/flow sensor 118 and can bedisplayed as the syringe fill volume. Subsequently, when the dose isadministered to the patient the display can indicate the dose volume.Alternately, the measured volume can be used to calculate a dose ingrams, milligrams, micrograms or other medication units instead ofmilliliters (mL) as shown in FIG. 10.

Information 18 can be bi-directionally exchanged and can includetransfer of data from recordkeeping system 30 (including medicationmanagement devices and systems, or any healthcare information computersystem) to dose preparation and transfer apparatus 8 for display to auser. Information 18 can provide additional data to the displayincluding, but not limited to medication delivery order data,patient-specific identifiers, general or medication-specific dosinglimits, data for contraindication checking, Broselowcolor/classification, patient drug allergies, patient weight, medicationdata, patient specific data, procedural cautionary data, errorprevention data, dose time data, physician instructions, drugmanufacturer's instructions, precautions, contraindications, etc.

FIG. 11 is a diagram illustrating a second medication dose preparationand transfer apparatus as in FIG. 3 with a display. A display 120 can beincluded on housing 12 of medication dose preparation and transferapparatus 8. Display 120 can include a user interface 130 providinginformation about the fluid transfer process or user guidance to ensurethe medication and volume transferred is correct and appropriate for itsintended use. For example a controlled substance dose preparation systemcan include an indication of the medication type and or concentrationconnected identified by ID Code 102. A caregiver can determine anappropriate dose volume and withdraw that dose volume from the primarycontainer 4. When the secondary container 6 is attached and the syringeplunger rod is pulled a medication dose is removed from the primarycontainer 4 into secondary container 6. That dose transfer is measuredby volume/flow sensor 118 and can be displayed as the syringe fillvolume. Subsequently, when the dose is administered to the patient thedisplay can indicate the patient dose volume.

Alternately, the entire volume of medication can be withdrawn from vial4. In this case any extra medication can be disposed of in a wastecontainer prior to dose administration to a patient. In this case theremaining volume is retained in syringe 6 for administration to thepatient. Information 18 about the medication (ID Code 102, the withdrawnvolume, the disposed of waste volume measured, the unique syringe IDCode 106) can all be transferred to recordkeeping system 30 for trackingand accounting of controlled substances. Dose volumes can be used tocalculate a dose in grams, milligrams, micrograms or other medicationunits instead of milliliters (mL) as shown in FIG. 11.

FIG. 12 is a diagram showing an example sequence of operation for thedevice in FIG. 11.

Step 1: A caregiver receives medication orders and prepares the dosepreparation and transfer apparatus 8 (300, 302, 304, 306).

Step 2: A caregiver assembles the medication containers (4 and 6) tomedication dose preparation and transfer apparatus 8 (308, 310, 312,314, 316, 318).

Step 3: The recordkeeping system 30 maintains a tracking record of IDcodes and transfer volumes (320) and the caregiver detaches thesecondary container 6 from apparatus 8 (322).

Step 4: The caregiver administers the medication to the patient anddisposes of unused medication waste (324, 326, 328). The recordkeepingsystem 30 accounts for the history of medication transferred with fromprimary medication container 4 to secondary medication container 6, thedose administered to the patient, and any residual waste disposal (330).

FIG. 13 is a diagram describing a detailed view of a sixth medicationdose preparation and transfer system 2 as in FIG. 1. In thisimplementation, medication ID Code 102 can be placed on the primarymedication container vial 4 (102 a) or on vial closure rim (102 b) ofthe primary medication container 4. In FIG. 13, medication containeremitter/detector 104 can identify medication ID Code 102 (102 a or 102b) on primary medication container (vial) 4 when it is not attached todose transfer fluid channel 10. Then, after ID Code 102 has beenidentified by dose preparation and transfer apparatus 8 it can be spikedor attached onto fluid channel 10, inverted and prepared for dosetransfer into secondary container 6. Secondary container 6 can stillhave ID Code 106 located at the fluid outlet and can be identified byemitter/detector 108. In this implementation dose transfer fluid channel10 couples primary medication container 4 to secondary container 6.Housing 12 can contain a volume/flow transducer 118 coupled to dosetransfer fluid channel 10 to measure an amount of medication transferredfrom vial 4 to syringe 6. The other features and functions of dosepreparation and transfer apparatus 8 described in FIG. 3 can be thesame.

FIG. 14 is a diagram describing a detailed view of a seventh medicationdose preparation and transfer system 2 as in FIG. 1. In thisimplementation, dose preparation and transfer apparatus 8 does notutilize dose transfer fluid channel 10 and instead uses a separate vialadapter 16. Housing 12 can contain identification emitter/detectors 104and 108 to read ID Codes 102 and 106 respectively. Housing 12 cancontain hardware and software elements 110 and 114 to process andtransmit or receive information 18 to/from recordkeeping system 30.

ID Code 102 can be placed on the primary medication container vial 4(102 a) or on vial closure rim (102 b) of the primary medicationcontainer 4 as in FIG. 13. Additionally, ID Code 106 can be placed onsecondary medication container 6 (106 a) or on the syringe fluid outlet(106 b) of secondary medication container 6. Emitter/detector 104 canidentify ID Code 102 (102 a or 102 b) on primary medication container(vial) 4 when it is not attached to dose transfer fluid channel 10.Emitter/detector 108 can identify ID Code 106 (106 a or 106 b) onsecondary medication container (syringe) 6 when it is not attached todose transfer fluid channel 10.

Then, after ID Codes 102 and 104 have been identified by dosepreparation and transfer apparatus 8 they can be associated with eachother via information transmission 18 using recordkeeping system 30.

When used, primary medication container (vial) 4 is coupled to secondarycontainer (syringe) 6 for fluid transfer. Vial 4 can be coupled (spiked)using medication container adapter 16 attached to the fluid outlet ofsecondary container (syringe) 6. Adapter 16 can contain dose transferfluid channel 10. Adapter 16 can be a vial adapter, a needle, a blunttip cannula, a needle-less luer adapter with spike as shown in FIG. 2 orany fluid transfer apparatus designed to transfer medication 20 fromvial 4 into syringe 6.

Following the coupling of vial 4 to syringe 6 through dose transferfluid channel 10, the assembly is inverted and prepared for dosetransfer. In this implementation dose transfer fluid channel 10 couplesprimary medication container 4 to secondary container 6. Measurement offluid transfer is done by the caregiver and manually entered intorecordkeeping system 30. The other features and functions of dosepreparation and transfer apparatus 8 described in FIG. 2 can be thesame.

The subject matter described herein can be embodied in systems,apparatus, methods, and/or articles depending on the desiredconfiguration. In particular, aspects of the subject matter describedherein can be realized in digital electronic circuitry, integratedcircuitry, specially designed ASICs (application specific integratedcircuits), computer hardware, firmware, software, and/or combinationsthereof. These various implementations can include implementation in oneor more computer programs that are executable and/or interpretable on aprogrammable system including at least one programmable processor, whichcan be special or general purpose, coupled to receive data andinstructions from, and to transmit data and instructions to, a storagesystem, at least one input device, and at least one output device.

These computer programs (also known as programs, software, softwareapplications, applications, components, or code) include machineinstructions for a programmable processor, and can be implemented in ahigh-level procedural and/or object-oriented programming language,and/or in assembly/machine language. As used herein, the term“machine-readable medium” refers to any non-transitory computer programproduct, apparatus and/or device (e.g., magnetic discs, optical disks,memory, Programmable Logic Devices (PLDs)) used to provide machineinstructions and/or data to a programmable processor. The term.“machine-readable signal” refers to any signal used to provide machineinstructions and/or data to a programmable processor.

The user interface can include, for example a cathode ray tube (CRT) ora liquid crystal display (LCD) monitor for displaying information to theuser. The user may input any information to the display device using akeyboard and a pointing device, such as for example a mouse or atrackball. Other possible input devices include, but are not limited to,touch screens or other touch-sensitive devices such as single ormulti-point resistive or capacitive trackpads, voice recognitionhardware and software, optical scanners, optical pointers, digital imagecapture devices and associated interpretation software, and the like.Other kinds of devices can be used to provide for interaction with auser as well. Further, the input from the user may be received in anyform, including, but not limited to, acoustic, speech, or tactile input.

Besides a digital feedback shown to the health care provider, thefeedback may be an audio signal, a video signal, or any form of sensoryfeedback such as a visual feedback, an auditory feedback, or tactilefeedback.

The implementations set forth in the foregoing description do notrepresent all implementations consistent with the subject matterdescribed herein. Instead, they are merely some examples consistent withaspects related to the described subject matter. Wherever possible, thesame reference numbers will be used throughout the drawings to refer tothe same or like parts.

Although a few variations have been described in detail above, othermodifications or additions are possible. In particular, further featuresand/or variations can be provided in addition to those set forth herein.For example, the implementations described above can be directed tovarious combinations and sub-combinations of the disclosed featuresand/or combinations and sub-combinations of several further featuresdisclosed above. In addition, the logic flows and steps for usedescribed herein do not require the particular order shown, orsequential order, to achieve desirable results. Other embodiments can bewithin the scope of the claim.

What is claimed is:
 1. An apparatus for transferring medication from a primary medication container to a secondary medication container, comprising: a housing having a fluid channel extending between a primary medication container port and a secondary medication container port; a primary medication container coupling configured to fluidically couple the primary medication container to the primary medication container port; at least one identification sensor disposed within the housing adjacent the primary medication port, the identification sensor configured to sense an information transfer element on the primary medication container, the information transfer element on the primary medication container identifying information about at least one of the primary medication container and a content of the primary medication container; and a communication module to transmit information obtained by and/or derived from the at least one identification sensor to a remote computing system.
 2. The apparatus of claim 1, further comprising a secondary medication container coupling configured to fluidically couple the secondary medication container to the secondary medication container port, wherein the at least one identification sensor is further configured to sense an information transfer element on the secondary medication container.
 3. The apparatus of claim 1, wherein the information transfer element on the primary container is at least one of an optical source, a magnetic source, a mechanical source, a switchable RFID source, a conductive source, and a proximity source.
 4. The apparatus of claim 3, wherein the information transfer element is a magnetically detectable strip.
 5. The apparatus of claim 3, wherein the information transfer element comprises a plurality of ridges and valleys facilitating detection by a micro-switch.
 6. The apparatus of claim 3, wherein the information transfer element comprises an RFID tag, wherein the RFID tag is open prior to connection to the apparatus and wherein the RFID tag is closed after connection to the apparatus.
 7. The apparatus of claim 3, wherein the information transfer element comprises at least one of etched and molded features.
 8. The apparatus of claim 3, wherein the information transfer element is a label adhered to the primary medication container.
 9. The apparatus of claim 1, wherein the information identified by the information transfer element includes at least one of: an NDC code, a segment of an NDC code, a unique identifier code, a human readable alphanumeric, a machine readable code, a name of the contents of the primary medication container, a manufacturer of the primary medication container, a re-packager of the primary medication container, a distributor of the primary medication container, a dosage form of a medication within the primary medication container, dose instructions, administration instructions for a specific patient, medication formulation, medication package form, medication package size, a contained volume of the primary medication container, a serial number of the primary medication container, a lot number of the primary medication container, and an expiration date.
 10. The apparatus of claim 1, wherein the primary medication container coupling comprises a spike to penetrate a barrier of the primary medication container.
 11. The apparatus of claim 1, wherein the primary medication container is a vial and the apparatus further comprises a vial adapter having the information transfer element disposed thereon.
 12. The apparatus of claim 1, wherein the communication module transmits the information obtained by and/or derived from the at least one identification sensor to the remote computing system to associate the information with the secondary medication container.
 13. The apparatus of claim 1, wherein the communication module wirelessly transmits information obtained by and/or derived from the at least one identification sensor to the remote computing system.
 14. The apparatus of claim 1, further comprising at least one flow sensor in fluid communication with the fluid channel, wherein the communication module further transmits information from the flow sensor to the remote computing system.
 15. A system, comprising: a primary medication container; a secondary medication container; an apparatus for transferring medication from the primary medication container to the secondary medication container, comprising: a housing having a fluid channel extending between a primary medication container port and a secondary medication container port, a primary medication container coupling configured to fluidically couple the primary medication container to the primary medication container port, a secondary medication container coupling configured to fluidically couple the secondary medication container to the secondary medication container port, at least one identification sensor disposed within the housing adjacent the primary medication port, the identification sensor configured to sense an information transfer element on the primary medication container, the information transfer element on the primary medication container identifying information about at least one of the primary medication container and a content of the primary medication container; and a communication module to transmit information obtained by and/or derived from the at least one identification sensor to a remote computing system.
 16. The system of claim 15, wherein the communication module transmits the information obtained by and/or derived from the at least one identification sensor to the remote computing system to associate the information with the secondary medication container.
 17. The system of claim 15, wherein the secondary medication container is a manually injectable container. 